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Correspondence
- Henri Roché, Pierre Kerbrat, Jacques Bonneterre (29 August 2006)
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Comments on "Complete Hormonal Blockade ..." by H. Roché et. al.
- Orhan Sencan, Mutlu DOGAN, Abdullah BUYUKCELIK, and Bulent YALCIN (11 August 2006)
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Henri Roché, professor of Medical Oncology 31 052 Toulouse cedex France, Pierre Kerbrat, Jacques Bonneterre
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Complete hormonal blockade versus epirubicin-based chemotherapy in premenopausal, one to three node-positive, and hormone-receptor positive, early breast cancer patients: 7-year follow-up results of French Adjuvant Study Group 06 randomized trial By Henri Roché*1, Pierre Kerbrat2, Jacques Bonneterre3 1Institut Claudius Régaud, Toulouse ; 2Centre Eugène Marquis, Rennes ; 3Centre Oscar Lambret, Lille, France * Correspondence to : Pr Henri Roché, Département d’Oncologie Médicale, Institut Claudius Régaud, 20-24 rue du Pont Saint-Pierre, 31052 Toulouse Cedex, France Phone : +33 5 61 42 41 29 Fax : +33 5 61 42 46 23 e-mail : roche.henri@claudiusregaud.fr In reply : We appreciate the interest of Dr Sencan et al in our article about “complete hormonal-blockade versus epirubicin-based chemotherapy as adjuvant treatment of intermediate-risk, early breast cancer patients”. We agree with the fact that a ten-node axillary resection is probably better than a five-node one, as requested in the FASG-06 protocol, to evaluate a one to three nodes involvement. However, the median number of resected nodes was 13 (range, 4 to 34) in the FEC50 arm, and 13 (range, 5 to 38) in the TAM-LHRHa arm. This level of axillary dissection should be considered as sufficient to properly evaluate the axillary-node involvement, and even if few patients have been underevaluated, the distribution would be similar between both treatment arms, and did not modify the accuracy of our conclusions. Regarding hormonal treatment, we have to consider that this trial was initiated at the beginning of 1990. At this period, the benefit of tamoxifen in premenopausal, hormone-receptor positive patients was not established. This has been clearly demonstrated in the EBCTCG overview presented in 1995, and published in 1998.1 Thereby, the purpose of our trial was to compare castration and tamoxifen with chemotherapy alone to evaluate their respective role. Our results showed that these approaches were equivalent. Concerning dose and duration of tamoxifen therapy: since 1995, the duration of tamoxifen treatment was extended to five years because of the EBCTCG overview results.1 This overview concluded that five years were better than one or two years. At the present time, no data allows to conclude to the inferiority of three or four years, and to provide a difference between 20 mg/day and 30 mg/day of tamoxifen. The FEC50 chemotherapy regimen used in this trial has been later replaced by the FEC100 regimen when the results of FASG-05 trial has been published.2 Clearly, the FEC100 regimen should have been a better option for this subset of patients, and the extent of our timely knowledge showed that the addition of a taxane-based regimen could be at least more effective than FEC100 for six cycles.3,4 The rate of venous thromboembolism has been well-monitored in our trial. This adverse event was not reported during the follow-up period of the FASG-06 trial, probably because of a young population . Noteworthy, no death was related to this event, and as it has been precised in our article that all deaths were related to the progression of breast cancer. When long-term results of adjuvant trials are presented, modern protocols seem to offer better outcomes to patients more recently treated, but older trials are able to give important lessons necessary to validate ongoing trials as TEXT, SOFT and PERCHE. References 1. Early Breast Cancer Trialists' Collaborative Group: Tamoxifen for early breast cancer: an overview of the randomised trials. Lancet 1998; 351: 1451-1467. 2. Bonneterre J, Roche H, Kerbrat P et al. Epirubicin increases long-term survival in adjuvant chemotherapy of patients with poor-prognosis, node- positive, early breast cancer: 10-year follow-up results of the French Adjuvant Study Group 05 randomized trial. J Clin Oncol 2005; 23: 2686- 2693. 3. Roché H, Fumoleau P, Spielmann M et al. Five years analysis of the PACS 01 trial: 6 cycles of FEC100 vs 3 cycles of FEC100 followed by 3 cycles of docetaxel (D) for the adjuvant treatment of node positive breast cancer. 27th San Antonio Breast Cancer Symposium; 8 – 11 December 2004; San Antonio, Texas. Abstract 27. 4. Martin M, Pienkowski T, Mackey J et al. Adjuvant docetaxel for node- positive breast cancer. N Engl J Med 2005; 352: 2302-2313. Conflict of Interest:None declared |
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Orhan Sencan, Medical Oncologist Ankara University, School of Medicine, Department of Medical Oncology, Cebeci, Ankara, 06590, Turkey, Mutlu DOGAN, Abdullah BUYUKCELIK, and Bulent YALCIN
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We have read the manuscript “Complete hormonal blockade versus epirubicin-based chemotherapy in premenopausal, one to three node- positive, and hormone-receptor positive, early breast cancer patients: 7- year follow-up results of French Adjuvant Study Group 06 randomised trial” by Roche et. al. with great interest.(1) Roche et al. conclude that adjuvant hormonal treatment is an alternative to chemotherapy in hormone receptor positive breast cancer patients. In this study, premenopausal node positive and receptor positive patients were given postoperatively either six cycles of adjuvant chemotherapy (FEC50) or tamoxifen (30mg/d, 36 months) with LHRH agonist (triptorelin, 3.75 mg monthly). We would like to make some comments on this trial. It has been known that, in order to accurately evaluate nodal status, at least ten axillary lymph nodes should be removed, if sentinel lymph node biopsy is not performed. In this study, as the removed mean node number is not reported, and removal of 5 nodes is accepted as inclusion criteria, some of the patients who were reported as having one to three node positive patients might have had more positive nodes, if ten or more lymph nodes had been removed during axillary dissection. In addition, it has been known that all hormone receptor positive breast cancer patients, even node negative premenopausal low risk group, should be given adjuvant tamoxifen for five years at a daily dose of 20 mg, since tamoxifen improves survival. The patients in chemotherapy arm seem to be not having received tamoxifen after chemotherapy. There is no information about the reasons for not giving tamoxifen after chemotherapy. Also the reason for using tamoxifen at a dose of 30 mg/day for three years, instead of 20 mg/day for 5 years is not given in the manuscript. In daily practice, patients with the inclusion criteria of this study receive both adjuvant chemotherapy and adjuvant hormonal therapy. As mentioned by the authors, 6 cycles of FEC50 is not as effective as FEC100, and this may be associated with the reported recurrence rates of chemotherapy arm. Venous thromboembolism is known to be one of the major side effects of tamoxifen, even at a dose of 20mg/day. There was no comment on this adverse effect; so we wonder whether if the patients were given prophylaxis for thromboembolism, or authors did notice a protective effect of the combination with LHRH analogue from this adverse effect. Reference: 1. Complete hormonal blockade versus epirubicin-based chemotherapy in premenopausal, one to three node-positive, and hormone-receptor positive, early breast cancer patients: 7-year follow-up results of French Adjuvant Study Group 06 randomised trial. Annals of Oncology 2006 17(8):1221-1227 Conflict of Interest:None declared |
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